Composition and preparation method of deslanoside injection

Abstract

The invention discloses a composition and preparation method of a deslanoside injection. According to formulation composition, the composition consists of deslanoside, ethanol, glycerin, sodium dihydrogen phosphate, disodium hydrogen phosphate and water for injection,wherein the use amount of the sodium dihydrogen phosphate is 0.02-0.8 g / ml, and the use amount of the disodium hydrogen phosphate is0.01-0.1 g / ml. The deslanoside injection disclosed by the invention is stable in quality, can tolerable hot pressurized sterilization, and F0 value is not less than 12; the sterility assurance levelis high, the process of the deslanoside injection is simple and efficient and the quality is controllable.

Description

Technical field[0001]The present invention relates to the field of pharmaceutical preparations, in particular to a stable composition of deacetyl lanolin injection that can withstand a heat-autoclave sterilization process and a preparation method.Background technique[0002]Deacetyl lanolin is a cardiotonic drug, also known as a positive inotropic drug. It is mainly used for the treatment of heart failure. It is especially suitable for patients with acute or exacerbated chronic cardiac insufficiency. It can also be used to control the ventricles with tachyarrhythmias. The ventricular rate of patients with atrial fibrillation and atrial flutter.[0003]At present, the only injection formulations of deacetyl lanolin are on the market. It was first marketed in Japan in 1986. The specification is 2ml: 0.4mg. According to the marketing data, the prescription is composed of lanolin, ethanol, glycerin and water for injection, and the acidity is pH5- 7.[0004]Deacetyl lanolin is colorless to whi...

AI Technical Summary

Problems solved by technology

[0010] According to the current published literature, deacetyllanatoside is unstable to heat, and the aseptic production process of sterilization and filtration is adopted in the preparation process of the preparation, which cannot realize the terminal sterilization process with F0≥12, such as autoclaving at 121°C for 12 minute

[0011] Chinese patent CN102961326A discloses a composition and preparation method of deacetylated lanatoside injection. A heat treatment method of sterilizing at 100°C for 30 minutes is selected. After conversion, the contribution of this condition to the F0 value is almost zero, and it is sterilized at 100°C. The 30-minute treatment method of bacteria is only an auxiliary sterilization method, which is far from reaching the sterility assurance level of terminal sterilization of sterile preparations

[0015] Aiming at the instability of deacetylated lanatosides, the inventors researched and discovered a composition of deacetylated lanatosides injection, which can withstand the terminal sterilization conditions of F0≥12, and the prepared injections were stabilized after the samples were retained. , stable pH, and the level of degradation impurities is much lower than that of commercially available products

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